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14 AUGUST 2015 Inhalation Delivering orally inhaled medications to the older patient with COPD and/or asthma: A challenge in both device design and clinical approach Introduction The inhaled delivery of therapeutic drugs presents signif- icant challenges to both clinician and patient, because orally inhaled products (OIPs) are relatively complex to use correctly, compared with other routes of drug admin- istration. 1 Challenges associated with adherence to pre- scribed medication are therefore compounded by the possibility that the older patient (defined arbitrarily as aged 65 years or older), as well as having multi-morbidi- ties, may lack manual dexterity due to commonly encountered diseases such as arthritis or Parkinsonism. 2, 3 Furthermore, the patient may have cognitive difficulties to a varying extent, and as a result is likely to be difficult to be taught correct inhaler technique in the first place, or may likely forget whatever training was received by the prescribing clinician or pharmacist. 4 The demographics in most developed countries mean that a greater propor- tion of the population will be reaching older age in the next 25-50 years. 5, 6 Given this background, it therefore behooves those involved in the development of new orally inhaled products to pay particular attention to the human factors associated with device use. 7, 8 Furthermore, the prescribing clinician and pharmacist, whose roles are vital in the chain of events that leads to successful medica- tion delivery, need to be aware of the key issues that should be addressed when helping the older patient use, and continue to use, their inhaler(s) correctly. 9, 10 Such patients commonly have one or more chronic obstructive lung diseases, in particular asthma and chronic obstruc- tive pulmonary disease (COPD). 11 Inhaled therapy is widely accepted as the norm for all but those with the most severe disease, in which additional therapy by other routes of administration may be needed. 12-14 This article seeks to highlight some key concerns, by examining the attributes of each of the major classes of OIPs of most rel- evance to the older patient. In addition, consideration is given as to how the Patient Information Leaflet, some- times called the Instructions for Use (IFU), which is a common aspect to their handling and maintenance, can be made more user-friendly in order to support and rein- force correct inhaler use. Overview of current therapy for obstruc- tion lung diseases Formulations A patient-by-patient individualistic approach to the pre- scribing-of inhaled medicines for treating the two major chronic diseases involving the airways of the lungs (asthma and COPD), is not yet a practical proposition. 15 Currently, both diseases are treated by topical adminis- tration of inhaled therapeutics, as being the safest route to achieve the desired degree of efficacy (Figure 1). In the case of asthma, inhaled corticosteroids (ICS) are given as controller therapy in appropriate dosing, depending on disease severity, to reduce the underlying inflammation of the airways. 13 ICS are usually combined with a long term (LABA) or ultra-long term (ULABA) beta 2 adren- ergic agonist in a single "combination" inhaler to miti- gate bronchoconstriction, and thereby providing symp- tom relief. A short term beta 2 adrenergic agonist (SABA) is also often provided in a separate inhaler as "rescue" medication for rapid relief of symptoms associated with bronchoconstriction, when felt necessary by the patient. The therapy for COPD is somewhat different, but still topical in nature. Here, an anticholinergic drug (antimuscarinic agonist) is the mainstay of therapy to treat the underlying inflammatory disease. 14 Short-act- ing antimuscarinic agonists (SAMAs) have been the tra- ditional therapy; these medications are often augmented with a SABA in a combination product for symptom Jolyon P. Mitchell, PhD, FRSC(UK), CChem, CSci Jolyon Mitchell Inhaler Consulting Services, Inc. Considerations for inhaler developers and prescribing clinicians